UCB, Otsuka discontinue immunology collaboration, focus on development of CNS drugs in Japan

UCB SA and Otsuka Pharmaceutical Co. Ltd. discontinued their immunology collaboration and will instead focus on developing drugs for central nervous system disorders in the Japanese market.

Specifically, the firms ended their agreement to co-develop and co-promote certolizumab pegol as a treatment for rheumatoid arthritis (RA) in Japan. Certolizumab pegol is marketed in the United States by UCB's U.S. subsidiary, UCB Inc., under the brand name Cimzia as a treatment for RA and Crohn's disease.

UCB said it would continue to develop its immunology pipeline in Japan and plans to submit an application to Japanese regulatory authorities this quarter for approval to market certolizumab pegol as a treatment for RA.

The companies will now focus the efforts of their collaboration on compounds such as levetiracetam, which is marketed in Japan under the brand name E Keppra as an adjunctive treatment for partial-onset seizures in adults with epilepsy, and rotigotine, a transdermal dopamine agonist patch developed to treat Parkinson's disease (PD) and restless legs syndrome (RLS).

Otsuka filed for regulatory approval of rotigotine in Japan for the PD and RLS indications last month; the firm obtained exclusive rights to develop and market the drug in Japan from UCB in 2002. Otsuka and UCB Japan Co. Ltd., another UCB subsidiary, co-market E Keppra in the Japanese market.

UCB and Otsuka said the decision to discontinue their immunology collaboration is "in line with Otsuka Pharmaceutical's clear priorities to focus in the future on CNS and oncology in its pharmaceutical business."

UCB markets levetiracetam and an extended-release formulation of levetiracetam in the United States as Keppra and Keppra XR. The immediate-release formulation is also available as a generic.

The Food and Drug Administration approved UCB's rotigotine patch as a treatment for early-stage idiopathic PD in 2007 under the brand name Neupro, but UCB recalled the product from the U.S. market in 2008 after ongoing monitoring showed that specific batches of the patch had deviated from the approved specification.

UCB submitted a supplemental New Drug Application (sNDA) to the FDA in 2009 for new refrigerated storage conditions of Neupro to alleviate the formation of crystals on the patch. In April 2010, the regulatory agency sent the firm a complete response letter and recommended that UCB reformulate the process.

Prior to the product's market recall, UCB had submitted sNDAs for Neupro in the treatment of advanced PD and RLS. However, in December 2008, the FDA sent a separate complete response letter for Neupro noting that the company had to resolve the issue of crystal formation in the patches.